Instructions: This form provides a template for documenting if an escalation in dose is warranted. Please provide the requested information in the identified fields. Information which is located in the protocol may be copied and pasted into the form. Complete the entire form then convert the form to PDF and digitally sign the PDF. Email the signed PDF to NCIOSROSafety@mail.nih.gov. Only one file should be submitted. In case of questions, please refer to 3B Dose Escalation Determination FAQs.

Protocol Information

Protocol Number:	[Enter Protocol Number]
Current Version:	[Enter Version Date]
Full Title:	[Enter Protocol Title]
PI:	[Enter PI Name]

Current Dose:	Dose Level	[Enter current dose level]	Actual Dose	[Enter current dose]
Next Dose:	Dose Level	[Enter next dose level]	Actual Dose	[Enter next dose]
Date of capture of the last data point of the last participants in the dose level:	{Enter date}

PI Attestation

The overall dose escalation criteria were <Choose an option> and the protocol <Choose an option> proceed to the next dose level.

Principal PI Signature (PIV card authenticated):
Email:	<Enter email address>

On<Enter date> the information supporting the dose escalation of protocol [Protocol Number] version [Version Date] from current dose level [Current dose level], dosage [Current dose] to next dose level [Next dose level], dosage [Next dose] were reviewed by the PI. All data supporting the dose escalation were present in the clinical database on {Enter date}.

The summary of protocol [Protocol Number] dose escalation scheme is presented in Appendix A.

The supporting safety information as of the cut-off-date of {Enter date} is presented in Appendix B.

The following dose escalation criteria were <Choose an option> as listed in the following Criteria table.

Instructions: Record each criterion on a separate row. Select Met or Not Met. To add additional rows, click the which appears below the Met /Not Met cell when clicking within the last row.

Criterion	Number of events contributing toward the criterion*	Criterion Met / Not Met
<Enter text>	<Enter text>	☐ Met	☐ Not Met
<Enter text>	<Enter text>	☐ Met	☐ Not Met
<Enter text>	<Enter text>	☐ Met	☐ Not Met

* Usually will be the number of participants meeting the DLT.

Additional comments: <Enter text>

Appendix A: Protocol and Dose Escalation Criteria Summary

Instructions: Sections A and B may be completed by providing the relevant text from the protocol.

Dosage Levels per Protocol Design:

<Enter dosage levels>

Dose Escalation Criteria:

<Enter dose escalation criteria>

Appendix B: Supporting Safety Information

Instructions:

Option 1. For each participant, complete the provided table with all adverse events that occurred whether they contribute to the dose escalation criteria or not.

Option 2. Prepare a table containing the requested information outside of the form. Replace the provided tables for individual participants with the externally prepared table.

The following is the supporting safety information as of cut-off-date of {Enter date}.

Participant number: <Enter participant number>

System Organ Class (SOC)	High Level Term (HLT)	Lowest Level Term (LLT)	Preferred Term (PT)	Additional Details	Grade	Onset Date	Resolution Date	Relationship 1	Relationship 2
<Enter text>	<Enter text>	<Enter text>	<Enter text>	<Enter text>	<Enter #>	<Enter date>	<Enter date>	<Enter text>	<Enter text>

Participant number: <Enter participant number>

System Organ Class (SOC)	High Level Term (HLT)	Lowest Level Term (LLT)	Preferred Term (PT)	Additional Details	Grade	Onset Date	Resolution Date	Relationship 1	Relationship 2
<Enter text>	<Enter text>	<Enter text>	<Enter text>	<Enter text>	<Enter #>	<Enter date>	<Enter date>	<Enter text>	<Enter text>

Participant number: <Enter participant number>

System Organ Class (SOC)	High Level Term (HLT)	Lowest Level Term (LLT)	Preferred Term (PT)	Additional Details	Grade	Onset Date	Resolution Date	Relationship 1	Relationship 2
<Enter text>	<Enter text>	<Enter text>	<Enter text>	<Enter text>	<Enter #>	<Enter date>	<Enter date>	<Enter text>	<Enter text>

Note: If additional participant tables are needed, then 1.) click inside the table and 2.) click the which appears in the right corner underneath the table.